ClinicalTrials.gg
Not yet recruitingNCT07867054MIM-BONDUpdated Oct 14, 2026

Effects of Maternal and Infant Massage on Breastfeeding and Mother-Infant Bonding

An interventional study of Infant Massage and Oxytocin Massage in Breastfeeding, Mother-Infant Bonding and Lactation, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment

Updated Oct 14, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Sex
Female
01

Study summary

This study aims to evaluate the effects of different massage techniques applied to mothers and infants on breastfeeding parameters and mother-infant bonding during the postpartum period. The study will investigate whether infant massage applied by mothers, oxytocin massage applied to mothers by fathers, or the combination of both interventions improves breastfeeding outcomes and mother-infant bonding compared with standard postpartum care.

Read the detailed description

The postpartum period is a critical period during which mothers and newborns adapt to important physiological, psychological, and social changes . During this period, maternal postpartum recovery, neonatal adaptation to life, successful initiation of breastfeeding, and the development of the mother-infant relationship are interrelated processes. In particular, the first hours and days after birth are critical for establishing breastfeeding behaviors, regulating milk production, and strengthening mother-infant interaction. Initiation of breastfeeding during the first hours after birth is one of the key practices supporting the newborn's access to colostrum, early immune protection, and the continuation of breastfeeding.

Lactation is a complex physiological process involving preparation of the breast for breastfeeding, milk synthesis and secretion, milk ejection (let-down) reflex, and maintenance of lactation. Effective infant suckling and regular breast emptying are important for successful continuation of this process. Inadequate breastfeeding may lead to decreased prolactin levels and adversely affect milk production. However, breastfeeding success cannot be explained solely by physiological mechanisms; it is influenced by multiple factors, including maternal knowledge, breastfeeding beliefs, sources of social support, childbirth experience, and breastfeeding self-efficacy.

Breastfeeding self-efficacy is defined as a mother's confidence in her ability to breastfeed her infant successfully and is considered an important determinant of breastfeeding initiation and continuation. Maternal education level, mode of delivery, postpartum care experiences, social support, and breastfeeding-related concerns may influence breastfeeding self-efficacy. In addition, hormonal changes, physical fatigue, sleep deprivation, adjustment to the maternal role, and concerns related to infant care may increase maternal stress during the postpartum period. Increased stress and anxiety may adversely affect oxytocin release and the milk ejection reflex, potentially resulting in reduced milk flow, shorter breastfeeding duration, and decreased maternal confidence in breastfeeding.

Therefore, there is a need for safe, feasible, and low-cost postpartum care interventions that address mothers' physiological and psychological needs. Oxytocin massage is a non-pharmacological complementary intervention used to support breast milk production and milk ejection. Oxytocin massage consists of circular massage movements applied along the neck, scapular, and spinal areas for approximately 15-20 minutes. It has been suggested that this intervention may stimulate the central nervous system through cutaneous and neural pathways, thereby increasing oxytocin release through the hypothalamic-pituitary pathway and supporting the milk ejection reflex. Previous studies have reported that oxytocin massage may have beneficial effects on milk volume, milk flow, and breastfeeding outcomes.

Another non-pharmacological intervention that may support mother-infant interaction is infant massage. Infant massage is an easily applicable caregiving approach that increases tactile communication between the mother and infant and may support the infant's physiological and behavioral regulation. Infant massage has been reported to increase vagal activity and potentially improve gastrointestinal function, nutrient absorption, and growth. Increased vagal activity may influence gastrin and insulin levels, potentially facilitating more efficient utilization of nutrients and supporting infant weight gain. In addition, by promoting infant relaxation and supporting sucking behaviors, infant massage may increase breastfeeding frequency, which may in turn stimulate prolactin secretion and contribute to milk production.

Infant massage may have beneficial effects not only on infant physical development but also on the mother-infant relationship. According to attachment theory, the mother-infant relationship begins at birth and develops through the mother's sensitive responsiveness to the infant's needs and reciprocal communication. Positive tactile contact during infant massage has been reported to support secure attachment, increase maternal sensitivity toward the infant, and strengthen mother-infant interaction.

The literature indicates that the effects of oxytocin massage and infant massage on breastfeeding, milk production, infant development, and mother-infant interaction have generally been evaluated separately. However, randomized controlled studies examining the effects of combining maternal oxytocin massage with infant massage performed by mothers on breastfeeding parameters, breastfeeding self-efficacy, and mother-infant bonding are limited. Since breastfeeding is a dynamic process shaped not only by maternal physiological factors but also by reciprocal mother-infant interaction, evaluating the effects of integrated tactile approaches targeting both the mother and infant is important.

This study is designed to evaluate the effects of maternal oxytocin massage and infant massage performed by mothers, when applied separately and in combination, on breastfeeding scores, time to breastfeeding initiation, breastfeeding duration and frequency, breastfeeding status at hospital discharge, breastfeeding problems, infant feeding method, breastfeeding self-efficacy, and mother-infant bonding during the postpartum period.

The originality of this study lies in its four-arm randomized controlled design, which comparatively evaluates two different non-pharmacological interventions targeting the mother and infant, both individually and in combination. This approach aims to provide evidence for a holistic model of postpartum care that considers the mother and infant together and to contribute new evidence to postpartum care practices.

The findings of this study are expected to contribute to the development of evidence-based interventions that can be implemented by midwives and nurses in postpartum care, support breastfeeding, strengthen mother-infant bonding, and promote family-centered care.

02

Conditions studied

  • Breastfeeding
  • Mother-Infant Bonding
  • Lactation

Browse trials for

03

In context

Breast Feeding

289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.

This study's planned enrollment of 136 is above the median of 97 across 228 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 693 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Mother:

  • Being primiparous.
  • Being within the first 24 hours postpartum.
  • Having a singleton birth.
  • Rooming-in with her infant during the postpartum period.
  • Having no physical or mental health condition that would prevent breastfeeding or participation in the study.
  • Being willing to regularly administer infant massage to her infant for 4 weeks postpartum.
  • Having no health condition that would prevent the mother or infant from receiving massage.
  • Being able to speak Turkish and having no condition that would interfere with communication.

Father:

  • Being present with the mother during the postpartum period.
  • Being able to speak Turkish and having no condition that would interfere with communication.
  • Being able to regularly administer oxytocin massage to the mother for 4 weeks postpartum.

Infant:

  • Being born at term (37-42 weeks of gestation).
  • Having a birth weight between 2,500 and 4,000 g.

Exclusion criteria

Exclusion Criteria:

  • The mother cannot be reached at 4 weeks postpartum.
  • Infant massage is performed fewer than twice per week.
  • Oxytocin massage is performed fewer than twice per week.
  • The infant is admitted to the neonatal intensive care unit.
  • The mother develops a postpartum complication (e.g., postpartum hemorrhage or suspected infection).
  • Participants assigned to the oxytocin massage group administer infant massage.
  • Participants assigned to the infant massage group administer oxytocin massage.
  • Participants assigned to the control group administer either oxytocin massage or infant massage.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (estimated)

Study arms

  • No intervention
    Control Group

    Mothers and their infants in the control group will not receive any experimental intervention, including oxytocin massage or infant massage, from the researcher. They will continue to receive the hospital's standard routine postpartum care and breastfeeding counseling according to the institutional protocol. Assessments will be conducted before hospital discharge (pre-test) and at 4 weeks postpartum (post-test).

  • Experimental
    Infant Massage Group

    Mothers in this group will administer infant massage to their own infants once daily for four weeks, for approximately 15 minutes per session, in accordance with the standardized infant massage protocol described above.

    Behavioral: Infant Massage

  • Experimental
    Oxytocin Massage Group

    Mothers in this group will receive oxytocin massage from their partners/their infants' fathers once daily for four weeks, in accordance with the standardized oxytocin massage protocol described above.

    Behavioral: Oxytocin Massage

  • Experimental
    Infant Massage and Oxytocin Massage Group

    Both interventions will be administered in this group. Oxytocin massage will be administered by the father to the mother, while infant massage will be administered by the mother to the infant. Both interventions will be performed once daily for four weeks in accordance with the standardized intervention protocols described above.

    Behavioral: Infant Massage and Oxytocin Massage

Interventions

  • BehavioralInfant Massage

    Mothers will be trained by the researcher to administer standardized infant massage to their own infants. After supervised practice before hospital discharge, mothers will administer infant massage once daily for 4 weeks, for approximately 15 minutes per session. Massage will be performed according to the standardized protocol.

  • BehavioralOxytocin Massage

    Fathers will be trained by the researcher to administer standardized oxytocin massage to the mothers. After supervised practice before hospital discharge, fathers will administer oxytocin massage once daily for 4 weeks according to the standardized protocol. Each session will last approximately 15-20 minutes.

  • BehavioralInfant Massage and Oxytocin Massage

    Mothers will administer standardized infant massage to their own infants, while fathers will administer standardized oxytocin massage to the mothers. Both interventions will be performed once daily for 4 weeks according to the standardized intervention protocols. Infant massage will last approximately 15 minutes, and oxytocin massage will last approximately 15-20 minutes per session.

06

What researchers measure

Primary outcomes

  1. Breastfeeding Quality

    Breastfeeding quality will be assessed using the Bristol Breastfeeding Assessment Tool. Changes in breastfeeding quality from baseline to post-test will be evaluated.Bristol Breastfeeding Assessment Tool The scale is completed by a midwife or nurse based on observation; it consists of four items-"positioning," "latching," "sucking," and "swallowing"-and uses a 3-point Likert scale. Each item is scored on a scale of 0 to 2. The lowest possible score on the scale is 0, and the highest is 8. Low scores indicate that breastfeeding is ineffective, while high scores indicate that breastfeeding is effective.

    Time frame: Before hospital discharge (pre-test) and at 4 weeks postpartum (post-test)

  2. Mother-to-infant bonding

    Mother-infant bonding will be assessed using the Mother-Infant Bonding Scale. Changes in Mother-Infant Bonding from baseline to post-test will be evaluated. The scale consists of eight items and uses a four-point Likert scale. Scale items are scored on a scale of 0-3, and the total possible score ranges from 0 to 24. Items 1, 4, and 6 on the scale represent positive emotions and are scored as 0, 1, 2, or 3; items 2, 3, 5, 7, and 8 represent negative emotions and are scored as 3, 2, 1, or 0. A high score on the scale indicates a bonding problem between the mother and the infant.

    Time frame: Before hospital discharge (pre-test) and at 4 weeks postpartum (post-test)

  3. Breastfeeding self-efficacy

    Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale. Changes in breastfeeding self-efficacy from baseline to post-test will be evaluated.Breastfeeding Self-Efficacy Scale It assesses how competent mothers feel regarding breastfeeding. The scale is a 5-point Likert-type scale, ranging from "I am not at all confident" (1 point) to "I am always confident" (5 points). The minimum possible score on the scale is 14, and the maximum is 70. The scale has no cutoff point, and a higher score indicates a higher level of breastfeeding self-efficacy.

    Time frame: Before hospital discharge (pre-test) and at 4 weeks postpartum (post-test)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant-level data.

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Also revised
primary outcomes
Registered
First appeared on the registry
Oct 9, 2026
Show all 2 updates
  1. Oct 14, 2026
    Primary outcomes Revised (4 changes)
    + 1 other change: responsible party
  2. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07867054
Responsible party
OZGE SEN (Research Assistant, Marmara University) — Principal investigator
First posted
Oct 9, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Özge Şen, PhD
Contact
ozgeylmz53@gmail.com
05393644201

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion